FDA clarified its stance on 3D-printed medical devices, accessories, components and parts during the COVID-19 pandemic in an update Thursday, amid potential shortages of key products like ventilators and personal protective equipment.
The agency voiced some reservations, including that 3D-printed PPE may be unlikely to provide the same level of protection as conventional, already authorized products.
- Yet, FDA is working to harness the capacity of the 3D printing industry, notably by entering into a collaboration with the National Institutes of Health, the VA, and additive manufacturing organization America Makes to distribute authorized designs to groups with the ability to make them.
The need to rapidly scale up production of PPE, ventilators and other pieces of medical equipment in response to the soaring number of COVID-19 cases has spurred the 3D printing sector around the world into action.
In the U.S., examples include an EUA-winning ventilator expansion device created by Prisma Health that would enable a single ventilator to be used on four patients at once, and efforts by Formlabs to 3D print swabs for test kits.
As 3D printers can quickly be repurposed to make low-cost medical equipment, the technology may be well suited to ease the strains the pandemic is placing on established medtech supply chains. However, the proliferation of devices made outside of the usual regulatory system also creates risks.
In its new frequently asked questions document on 3D printing during the pandemic, FDA warns that “3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.” FDA’s guidance points readers to a CDC resource on optimizing the use of face masks that suggests using bandanas and scarfs as a last resort but makes no mention of 3D-printed PPE.
While FDA has reservations about 3D-printed PPE, it is more upbeat on using the technology to make accessories, components or parts for medical devices. FDA backs use of original parts when possible and warns that some complex products are not easily 3D printed. Yet, the agency also set out a path to market for 3D printers, advising them to work with medical device producers, use plans for original parts and check their components fit and work before using them in clinical settings.
The availability of validated designs for 3D-printed medical devices would take some of the risk out of the field. Distribution of such designs would enable anyone with a 3D printer to make a device that has been through some level of testing to validate it works.
FDA is helping to make such validated designs available. On Wednesday, NIH published a statement about its work with FDA, the Department of Veterans Affairs and 3D printing accelerator America Makes. The collaborators plan to evaluate the effectiveness of 3D-printed parts and identify designs that will be most useful to healthcare providers and patients in the event a conventional device is in short supply.